瑞舒伐他汀钙治疗原发性高胆固醇血症的有效性和安全性II期临床试验

The efficacy and safety of rosuvastatin calcium in treatment of the patients with primary hypercholesterolemia in the phase II clinical trials

目的:评价不同起始剂量的瑞舒伐他汀钙治疗原发性高胆固醇血症患者的有效性和安全性。方法:采用多中心、随机、双盲、双模拟、阳性药平行对照临床试验设计,经4周安慰剂导入和饮食控制期后筛选出符合入选条件的患者进入为期8周的不同起始剂量的药物(分别给予瑞舒伐他汀钙5或10mg、或阿托伐他汀钙10mg)治疗期。治疗至第4周末时,如患者的低密度脂蛋白胆固醇(LDL-C)≥3.12mmol/L(120mg/dl),则所服药物剂量加倍。结果:治疗8周后,各组LDL-C水平均较基线时明显下降(P<0.05),且瑞舒伐他汀钙10mg组与阿托伐他汀钙10mg组间的差异有统计学意义(P<0.05)。以相差5个百分点为非劣效判断标准,发现瑞舒伐他汀钙5和10mg两组降低LDL-C水平的疗效均不劣于阿托伐他汀钙10mg组。结论:瑞舒伐他汀钙5和10mg治疗在中国人群中的降脂疗效与阿托伐他汀10mg相当,均具有良好的安全性和耐受性。

Objective： The different initial doses ofrosuvastatin calcium were evaluated for the efficacy and safety in treatment of the patients with primary hypercholesterolemia. Methods： The research was designed by the controlled clinical trial of multicentre, randomized, double-blind, positive drug parallel-group. After 4 weeks of placebo lead-in/diet control period, the qualified patients were screened and assigned to be administrated for the 8 weeks of the different initial dose （rosuvastatin calcium 5 mg, or rosuvastatin calcium 10 mg, or atorvastatin calcium 10 mg）, respectively. In the 4th week, if the low density lipoprotein cholesterol （LDL-C） was 〉 3.12 mmol/L （120 mg/dl）, the medication dose would be doubled. Results： After 8 weeks＇ treatment, each LDL-C level was significantly decreased vs. the average baseline （P〈0.05）, and the difference between the atorvastatin calcium 10 mg group and rosuvastatin calcium 10 mg group was statistically significant （P〈0.05）. As 5 percentage difference was the criterion for non-inferiority, LDL-C lowering effect of rosuvastatin calcium 5 mg and 10 mg group was not inferior to that of atorvastatin calcium 10 mg. Conslusion： Rosuvastatin calcium 5 and 10 mg lipid-lowering effect is as effective as that of atorvastatin calcium 10 mg, and has good safety and tolerability.